Patient anonymity when responding

What restrictions apply for a patient branded Rx app where the patient inputs data about their usage of the product yet the data remains anonymous to the pharmaceutical company but known to the physician? For example, the physician will prescribe one particular usage and tell the patient to change the way they use the same product after a certain amount of time (as per the product monograph). The patient provides responses that would remain completely anonymous to the pharmaceutical client. However, the pharma company would collect the grouped data as real-world evidence. Moreover, the physician who prescribed the product and recommended that the patient use this particular app would like to receive his or her patients' responses in order to follow the patients' clinical journey in between visits.

The app itself would be reviewed against the standards of the code. While all functionality of the app should be included in the submission, the manufacturer’s legal department should ensure that all Federal and Provincial requirements pertaining to the collection, usage, storage and distribution of patient data are adhered to.